BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW MICROSCISSOR TIP, DISPOSABLE

    MDR report key: 21018735 · Received December 26, 2024

    Report

    Report Number
    1223422-2024-00049
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 4, 2024
    Report Date
    April 16, 2025
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    UDI-DI
    00811099010036
    PMA / PMN Number
    K213127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, MICROLINE SURGICAL, INC IS CONDUCTUING AN INVESTIGATION BASED ON OTHER DEVICES OF THE SAME LOT THAT HAD BEEN PREVIOUSLY RETURNED, AS WELL AS WITH OTHER DISPOSABLE SCISSOR TIPS SENT BY THE DISTRIBUTOR. ONCE THE INVESTIGATION IS CONDUCTED, A FINAL ADVERSE EVENT REPORT WILL BE SUBMITTED WITH THE RESULTS.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE RECENT INQUIRIES FROM AMCO INCORPORATED, PERTAINING TO HEAT SHRINK FALLING OFF OF MICROLINE SURGICAL INC.'S RENEW DISPOSABLE TIPS (CAT # 3112), WE HAVE RECEIVED THE COMPLAINTS. WE APOLOGIZE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED. MICROLINE SURGICAL INC. HAS INITIATED A VOLUNTARY RECALL ON ALL PARTS OF AFFECTED LOT 00172110 (CAT # 3122) AND ISSUED A CORRECTIVE ACTION (CAR-0200) TO ADDRESS THIS PROBLEM. OTHER IMMEDIATE CONTAINMENT CARRIED OUT BY MICROLINE SURGICAL INC. INCLUDED INSPECTING ALL GRASPER TIPS IN PROCESS AND IN OUR STOCKROOM FOR THIS DEFECT. ADDITIONALLY, OUR QUALITY ASSURANCE TEAM PERFORMED AN INDEPENDENT VERIFICATION OF HEAT SHRINK PRIOR TO RELEASE FOR EVERY LOT OF TIPS BEING MANUFACTURED ON THE AFFECTED ASSEMBLY LINE UNTIL THE CAR INVESTIGATION WAS COMPLETE. THE ROOT CAUSE IDENTIFIED THROUGH THE INVESTIGATION OF CAR-0200 WAS THAT THE TIPS WERE NOT PROCESSED IN ACCORDANCE WITH THE WORK INSTRUCTION. THE PARTS WERE NOT SUBJECTED TO ELEVATED TEMPERATURE IN AN OVEN AS THE ASSEMBLY PROCESS CALLS FOR. THEREFORE, THE HEAT SHRINK DID NOT FIRMLY ATTACH TO THE TIP ASSEMBLIES. WHEN INVESTIGATING FURTHER THE FOLLOWING FACTORS WERE IDENTIFIED AS CONTRIBUTING TO THE PROCESS FAILURE: THE STATE OF WORK OF MATERIAL WAS NOT PROPERLY IDENTIFIED DURING BREAK TIMES AND THE END OF THE DAY. THE WORK AREA HAD NO VISIBLE STAGING AREA TO IDENTIFY STATUS OF PARTS (AWAITING OVEN VERSUS ALREADY PROCESSED THROUGH OVEN). INSUFFICIENT INSPECTION AND TRAINING OF OPERATORS. THE OVEN PROCESS LOG DOES NOT INCLUDE THE NUMBER OF TIPS PROCESSED. THERE IS NO METHOD TO RECONCILE IF ALL PARTS WERE PLACED IN THE OVEN. FOR THE IMPLEMENTATION STAGE OF CAR-0200 THE ASSEMBLY LINE WORK AREA WAS REARRANGED TO PROVIDE A SEPARATE HOLDING AREA FOR TIPS PROCESSED THROUGH THE HEAT SHRINK OVEN. PRODUCT IS HELD IN THIS AREA UNTIL IT IS 100% INSPECTED AND RELEASED FOR FURTHER PROCESSING. OUR ASSEMBLY WORK INSTRUCTION WAS UPDATED TO INCLUDE MORE DETAIL ON HOW TO PERFORM A TACTILE PULL/PUSH TEST WHICH WILL ENSURE THE HEAT SHRINK IS SECURE. OUR INSPECTION PROCEDURE WAS REVISED TO INCLUDE A STEP ON VISUALLY EXAMINING THE SHRUNK TUBING. A STEP WAS ALSO ADDED TO OUR PACKAGING WORK INSTRUCTION AS ANOTHER LEVEL OF VERIFYING THAT THE HEAT SHRINK IS FIRMLY ATTACHED. LASTLY, THE OVEN PROCESS LOG USED IN TIP ASSEMBLY WAS REVISED TO RECORD THE QUANTITY OF TIPS PROCESSING THROUGH THE OVEN. ALL OPERATORS HAVE BEEN TRAINED TO THE UPDATED PROCEDURES. CAR-0200 IS CURRENTLY IN THE VERIFICATION STAGE WHERE WE WILL ENSURE THE IMPROVEMENTS IMPLEMENTED ARE STILL BEING PRACTICED AND WE WILL MONITOR CUSTOMER COMPLAINTS FOR THIS DEFECT.

    Description of Event or Problem · 0

    IN ONE CASE, THE HEAT SHRINK FELL INTO THE ABDOMINAL CAVITY AND WAS RETRIEVED AND DISPOSED AT THE HOSPITAL. IN THE OTHER TWO CASES, THE HEAT SHRINK FELL OUTSIDE THE SURGICAL FIELD SO NO HARM TO THE PATIENT. THESE TWO PIECES WERE RETRIEVED AND AVAILABLE.

    Description of Event or Problem · 0

    IN ONE CASE, THE HEAT SHRINK FELL INTO THE ABDOMINAL CAVITY AND WAS RETRIEVED AND DISPOSED AT THE HOSPITAL. IN THE OTHER TWO CASES, THE HEAT SHRINK FELL OUTSIDE THE SURGICAL FIELD SO NO HARM TO THE PATIENT. THIS TWO PIECES WERE RETRIEVED AND AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814167 RENEW MICROSCISSOR TIP, DISPOSABLE FLEXIBLE ENDOSCOPIC SCISSORS, SINGLE-USE GEI MICROLINE SURGICAL INC 3122 00172110 00811099010036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown